Increasing value and reducing waste in biomedical research regulation and management

Abstract

After identification of an important research question and selection of an appropriate study design, waste can arise from the regulation, governance, and management of biomedical research. Obtaining regulatory and governance approval has become increasingly burdensome and disproportionate to the conceivable risks to research participants. Regulation and governance involve interventions that are assumed to be justified in the interests of patients and the public, but they can actually compromise these interests. Inefficient management of the procedural conduct of research is wasteful, especially if it results in poor recruitment and retention of participants in well designed studies addressing important questions. These sources of waste can be minimised if the following four recommendations are addressed. First, regulators should use their influence to reduce other causes of waste and inefficiency in research. Second, regulators and policy makers should work with researchers, patients, and health professionals to streamline and harmonise the laws, regulations, guidelines, and processes that govern whether and how research can be done, and ensure that they are proportionate to the plausible risks associated with the research. Third, researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through use of research designs known to reduce inefficiencies, and further research should be done to learn how efficiency can be increased. Finally, everyone, particularly those responsible for health-care systems, should promote integration of research into everyday clinical practice. Regulators and researchers should monitor adherence to each of these recommendations and publish metrics.

Developing the Librarians' Role in Supporting Grant Applications and Reducing Waste in Research: Outcomes From a Literature Review and Survey in the NIHR Research Design Service

“…Five years later, The Lancet ran a symposium "Research: increasing value, reducing waste" looking at the increasing global investment in biomedical research, and how much of this research does not lead to worthwhile achievements. It produced a series of reviews, each looking at the problem from a different angle: (i) that funding decisions should be based on how relevant the research is to users ; (ii) that the most appropriate research design methods and analysis should be used (Ioannidis et al, 2014); (iii) that regulators of research should use their influence to reduce other causes of waste and inefficiency in research (Al-Shahi Salman et al, 2014); (iv) the importance of fully reported and accessible research information (Chan, Song, & Vickers, 2014); and finally (v) the importance of unbiased and usable research reports (Glasziou, Altman, & Bossuyt, 2014).…”

The role of editors in reducing waste in research: the REWARD campaign

“…10 Moreover, we acknowledge that The Lancet has the advantage of a large team of full-time, permanent staff, whereas many other groups have much more limited resources. However, through the standards we keep in the peer review and editorial process, we can have a positive influence on the reporting, interpretation and even the design and conduct of clinical trials.…”

Explanation and Elaboration Document for the STROBE‐Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology—Veterinary Extension

“…Some omissions can seriously limit the utility of the research by either hiding limitations or creating unwarranted doubt about the studies’ conclusions. These omissions, in turn, increase research wastage 8, 9, 10, 11, 12, 13. Study results are usually used by people other than the manuscript authors to make decisions.…”